Principal Product Quality Leader - Combination Products


If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Principal Product Quality Leader- Combination Products


What you will do

Let's do this. Let's change the world. Amgen's corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader - Combination Products. As the Product Quality liaison to multi-functional teams, you will provide Quality principles aligning with device design control, change control and NC/CAPA, risk management, and human factors engineering, to ensure final product stays in sync with dynamic global regulations and standards. The role you will support includes:
  • Train and educate peers and managers on combination product requirements, standards and regulations
  • Maintain consistency and alignment between the relevant sections of regulatory submissions and responses to questions, and provide support for audits and inspections
  • Support a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories
  • Support end-to-end control strategies for combination products including in-process controls, specifications and stability testing strategies
  • Lead continuous improvement activities related to specifications and stability of combination products
  • Support investigations, root cause analyses, risk assessments, signal detection, and triage improvements
  • Collaborate cross-functionally and with Senior Management to drive improvements and provide support to other Quality focus areas
  • Collaborate closely with Final Product Technologies Quality (FPTQ) Leadership to progress business initiatives
  • Benchmark with industry regarding combination product specifications and testing strategies
  • Provide effective, multi-functional Quality leadership and program support for late phase and commercial programs relating to annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments
  • Author regulatory filing sections and responses to questions
  • Support science and risk-based evaluation of sophisticated process and product quality data, including ability to develop strategies to provide novel solutions for patients


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Product Quality professional we seek is a Leader with these qualifications.

Preferred Qualifications:

  • Bachelor's or Master's degree in Life sciences, Engineering, or related subject area 7 years of professional experience in Program Management, Operational Excellence, Quality, R&D, and/production
  • Show strength in oral and written communication of sophisticated information to Product Quality leadership, peers and regulatory agencies
  • Extensive knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals and device/combination products, including experience with Notified Bodies
  • Deep medical device/combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects move through design controls
  • Subject matter authority in Risk Management for combination products
  • Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis
  • Strong project management skills / ability to lead all aspects of numerous projects simultaneously
  • Lean six-sigma greenbelt/blackbelt
  • Proven strong leadership, negotiation and influencing skills along with sophisticated communication and analytical skills
  • Effective and timely decision making
  • Ability to work effectively in global multi-functional teams and in a highly matrixed team environment
  • Willingness to learn and be persistent
  • Ability to adapt to changing business needs
  • Willing and able to travel up to 20%

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

We understand that to optimally sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.